Core Insights - Soligenix, Inc. has published results from its Phase 2a study of SGX945 (dusquetide) for treating Behçet's Disease, indicating promising outcomes for patients with oral ulcers associated with the condition [1][2][5] Study Results - The Phase 2a study showed beneficial effects for 7 out of 8 patients over 4 weeks of treatment, with sustained improvements noted during the follow-up period [2][4] - SGX945 demonstrated a 40% improvement in the area under the curve (AUC) for the mean number of ulcers compared to placebo, while the approved drug apremilast showed a 37% improvement [3][9] - Improvements in oral pain were consistent with the AUC measurements, with 7 of 8 patients reporting benefits such as reduced duration and number of oral ulcers [4][9] Safety and Tolerability - SGX945 was well-tolerated with no treatment-related adverse events reported, contrasting with common side effects associated with apremilast, such as diarrhea (41%), nausea (19%), and headache (14%) [4][9] Future Development Plans - The company plans to reformulate SGX945 for home-based treatment via subcutaneous injection and aims to expand its development into other inflammatory conditions related to the innate immune system [5][10] - Soligenix holds a strong intellectual property position for dusquetide and has received Fast-Track and Orphan Drug designations from the FDA for its treatment of Behçet's Disease [10][12] Market Context - Behçet's Disease is a chronic condition affecting approximately 1 million people worldwide, with significant unmet medical needs, particularly in managing symptoms like oral ulcers [11][12] - Current treatments, including apremilast, require continuous administration and are associated with high costs and side effects, highlighting the potential market opportunity for SGX945 [14][15]

Core Insights - Soligenix, Inc. has completed a Phase 2a proof of concept study for SGX945 (dusquetide) in treating Behçet's Disease, demonstrating biological efficacy [1][5] - The study showed that SGX945 had comparable outcomes to apremilast, the only approved drug for oral ulcers in Behçet's Disease, with a 40% improvement in ulcer count compared to placebo [3][4] - SGX945 was well-tolerated with no treatment-related adverse events, contrasting with common side effects associated with apremilast [4][5] Study Design and Results - The Phase 2a study was an open-label trial involving 8 patients with mild to moderate Behçet's Disease, receiving SGX945 as a twice-weekly intravenous infusion for 4 weeks [6] - The primary endpoint was the area under the curve (AUC) for the mean number of ulcers over time, with SGX945 showing a 40% improvement compared to placebo, while apremilast showed a 37% improvement [3][4] - Improvements in oral pain were also noted, with 7 out of 8 patients reporting benefits from SGX945 treatment [4][5] Future Development Plans - The company plans to reformulate SGX945 for home-based treatment using subcutaneous injection, aiming to enhance patient convenience and compliance [5] - There is an intention to conduct a follow-on placebo-controlled Phase 2 study to further explore SGX945's benefits in Behçet's Disease [6] - The company is looking to expand dusquetide's development into other innate immune-related inflammatory conditions as part of its long-term strategy [5] Market Context - Behçet's Disease is a chronic condition affecting approximately 1 million people worldwide, with significant unmet medical needs for effective treatments [6][11] - Current treatments, including apremilast, have limitations such as high costs and side effects, highlighting the potential market opportunity for SGX945 [12]